PRECLINICAL DEVELOP. OF A NEW DRUG FOR PCP AND MALARIA

描述（根据申请改编）：本阶段的总体目标 II STTR申请是为了完成NPC 1161 B的临床前研究， 治疗和预防疟疾的有前途的新药候选者。的 药物在动物模型中也非常有效，用于治疗或预防 卡氏肺孢子虫病和利什曼病。这个项目是 STTR第一阶段项目的持续合作， Elsohly Laboratories Inc.，牛津MS和国家自然科学中心 MS（UM）大学的产品研究。 在第二阶段的申请中，这些研究将扩展到完成 研究新药备案所需的信息包 应用程序.将通过一项工作计划实现这一目标， 实现以下具体目标：1）确定理化 GMP原料药NPC 1161 B的特性、纯度和稳定性，评估 药物与常用胶囊形成赋形剂的相容性; 2） 在灵长类动物模型中评价NPC 1161的立体异构体（NCP 1161 A和NCP 1161 B） 相对抗疟疗效、毒性和代谢/动力学; 3） 开发用于临床研究的NCP 1161 B的分析方法和配方 (drug产品）并进行加速稳定性研究; 4）准备并提交 IND申请。 拟议商业应用：不可用

DESCRIPTION (Adapted from the application): The overall objective of this Phase II STTR application is to complete the preclinical studies for NPC 1161B, a promising new drug candidate for the treatment and prophylaxis of malaria. The drug is also very effective in animal models for the treatment or prevention of Pneumonocysis carinii (PCP) and leshmaniasis. This project is the continuation of the STTR Phase I project and a continuing collaborative effort between Elsohly Laboratories Inc., Oxford MS and The National Center for Natural Products Research of the University of MS (UM). In this Phase II application, these studies will be extended to complete the package of information necessary for the filing of the Investigational New Drug application. The objective will be accomplished through a plan of work to achieve the following specific aims: 1) Determine the physiochemical characteristics purity and stability of the GMP drug substance NPC1161B, assess compatibility of the drug with commonly used capsule formation excipients; 2) Evaluate the stereoisomers of NPC1161 (NCP1161A and NCP1161B) in primate models for relative antimalarial efficacy, toxicity, and metabolism/kinetics; 3) Develop analytical methods and a formulation of NCP1161B for clinical studies (drug product) and conduct accelerated stability studies; 4) Prepare and submit IND application. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE